Package Insert: Information for the User

Lavirk 50mg/g gel

Aciclovir

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult a pharmacist.
• Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.
• Consult a doctor if you worsen or do not improve after 10 days.

5. Storage of Lavirk

6. Contents of the container and additional information

Lavirk is a medication used for the treatment of symptoms (such as tingling, burning, and discomfort) of recurrent herpes labialis caused by the herpes simplex virus.

Clinical trials, conducted in comparison with a placebo cream, demonstrate statistically significant efficacy of aciclovir cream in reducing healing time and duration of pain:

• Healing time was up to 22% faster (mean duration reduced to 0.5 days)
• Pain disappeared approximately 20% faster (mean duration reduced to 0.4 days)

Approximately 60% of patients initiated treatment at an early stage (prodrome or erythema) and 40%, at a late stage (papule or vesicle).

To help you understand why you have herpes labialis and ensure you use this medication correctly, we ask that you read this leaflet carefully.

Keep this leaflet; you may need to read it again.

You should consult a doctor if it worsens or does not improve after 10 days.

Do not use Lavirk:

• If you are allergic (hypersensitivity) to aciclovir, valaciclovir, propylene glycol or to any of the other components of this medication (included in section 6).
• For eye and genital herpes simplex infections or any other type.
• If you suffer from immune system problems that may make you more prone to infections.
• Do not use it inside the mouth (for example, for mouth ulcers) or the nose.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

Use this medication as soon as possible after the onset of the infection; it is ideal to use it when the first symptoms of herpes labial appear (such as tingling and itching).

Avoid touching your eyes. If you are unsure whether you have herpes labial, contact your doctor.

This medication is not recommended for use in people with severe immune system failure (e.g., patients with AIDS or individuals who have received a bone marrow transplant). In this case, oral aciclovir treatment may be considered. Such individuals are encouraged to consult a doctor about the treatment of any infection.

Other medications and Lavirk

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

In principle, this medication does not affect any other medication you may be using.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Lavirk contains propylene glycol (E-1520)

This medication contains 300 mg of propylene glycol in each gram of gel.

Propylene glycol may cause skin irritation.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The amount of gel inside this package is sufficient for a herpes labial outbreak. It is important to start treatment immediately after the first symptoms of herpes labial appear. Many patients notice when they are about to have a herpes labial due to the sensation of burning, itching, and tingling. It is recommended to apply this medication as soon as possible, for example, during the tingling phase. Treatment can also be initiated during the blister phase.

Follow the instructions carefully.

Adults and children over 12 years old

Apply the gel with the help of your finger to cover the affected area completely, including the outer edges of the vesicles.

Apply it to the affected area 5 times a day at approximately 4-hour intervals, without applying it at night. If you forget a dose, apply it as soon as you remember and continue as before.

Continue treatment for 4 days (4 x 5). If your herpes labial has not healed after this time, you can use the gel for another 6 days. If your herpes labial has not completely healed after 10 days, or if it worsens, consult your doctor.

Do not use more than the recommended dose.

Use in children

Children between 2 and 12 years old: consult your pharmacist or doctor.

Wash your handsbefore and after applying this medication to avoid transferring or worsening the infection.

If you use moreLavirk than you should

Talk to your doctor or pharmacist if you use too much Lavirk, inform them and bring the packaging with you.

If you accidentally swallow some gel, it is unlikely to have any side effects; however, you must inform your doctor or pharmacist.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20, consult your doctor or pharmacist.

If you forgot to useLavirk

If you forget to apply a dose of this medication, do not worry and apply it as soon as you remember. Then, continue as before.

In case of doubt, consult your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Normally, patients tolerate this medication well; however, some people may experience adverse effects. Burning or stinging sensation may appear after application. These effects will disappear quickly.

In some cases, the patient's skin may be affected by mild redness, itching, dryness, or peeling, skin eruptions, urticaria, or rashes.

In rare cases, allergic reactions, such as swelling of the lips, face, and eyelids, may occur. In this case, stop using the medication and inform your doctor.

Communication of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the reach and sight of children.

Check the expiration date before starting treatment.

Do not use this medication after the expiration date that appears on the packaging and on the tube after «CAD». The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the packaging shows signs of deterioration.

Medicines should not be thrown away through the drains or in the trash. Dispose of the packaging and medications that you no longer need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Remember

Herpes labial is contagious.

The virus can infect other parts of the body. To reduce the risk of transmission of the infection, do not allow others to touch the herpes labial, do not share your towel, etc.

You should avoid kissing and oral sex if you or your partner has active herpes labial. Always wash your hands before and after touching the herpes labial.

Avoid touching your eyes. Herpes simplex eye infection can cause corneal ulcers. Avoid kissing, especially children, if you have a herpes labial.

Do not break the blisters or touch the scabs. Not only could you infect the herpes labial with other germs, but you could even infect your fingers with the virus.

Do not share your eating and drinking utensils (forks, glasses, etc.).

Information for the user

A herpes labial is an infection caused by the herpes simplex virus (HSV), which is inactive (in a latent state) in the nerve ganglia of the face.

When does the first infection occur?

The first infection usually occurs in early childhood, probably after being kissed by a person with the infection. The virus passes through the skin, moves to a nerve, and remains in a nerve junction indefinitely. Normally, no herpes labial outbreak occurs with the first contact.

What can activate the virus?

There are several factors that can activate the virus, such as colds, flu, menstruation, fatigue, emotional distress, stress, physical injuries, strong sunlight, and climate changes. Once activated, the virus travels from the nerve to the skin and around the lips, where it causes herpes labial.

Composition of Lavirk

• The active principle is aciclovir. Each gram of gel contains 50mg of aciclovir.
• The other components (excipients) are carboxypolymethylene, PVP 30, menthol crystal, trometamol, glycerin, propylene glycol, and purified water.

Appearance of Lavirk and contents of the packaging

Lavirk is a soft, white to yellowish gel that forms a transparent film after application.

Lavirk is available in an aluminum tube of 2g, a 5g pump dispenser, and an aluminum tube of 15g.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

LABORATORIUM SANITATIS, SL (LABSAN)

Parque Tecnológico de Álava

C/ Leonardo Da Vinci 11

01510 Miñano, Álava

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Spain: Lavirk 50 mg/g gel

Portugal: Lipovir 50 mg/g Gel

Date of the last review of this leaflet: July 2020.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.